NCT01529736

Brief Summary

Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

6 years

First QC Date

February 7, 2012

Last Update Submit

March 24, 2022

Conditions

Partial EdentulismTooth Disease

Keywords

edentulismdental implantsearly loadingcrestal bone levelhigh torque insertionlow torque insertionrandomizedOsseotiteclinical study

Outcome Measures

Primary Outcomes (1)

  • primary stability countertorque measures

    resistance to countertorque measures showing primary stability success of implants

    4 months

Secondary Outcomes (1)

  • cumulative success rate

    1 year

Study Arms (2)

High torque insertion

EXPERIMENTAL

High torque insertion

Procedure: High torque insertion

Low torque insertion

ACTIVE COMPARATOR

Low torque insertion

Procedure: Low torque insertion

Interventions

High torque insertionPROCEDURE

Osseotite implant placed with high insertion torque forces

Also known as: Osseotite endosseous dental implant
High torque insertion
Low torque insertionPROCEDURE

Osseotite implant placed with low insertion torque forces

Also known as: Osseotite endosseous dental implant
Low torque insertion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients of either sex and older than 18 years of age
  • patients needing a minimum of 3 implants to treat partial edentulism
  • patients physically able to tolerate surgical and restorative dental procedures
  • patients agreeing to all protocol visits

You may not qualify if:

  • patients with infection or severe inflammation at the intended treatment sites
  • patients smoking greater than 10 cigarettes per day
  • patients with uncontrolled diabetes mellitus
  • patients with uncontrolled metabolic diseases
  • patients who received radiation treatment to the head in the past 12 months
  • patients needing bone grafting at the intended treatment sites
  • patients known to be pregnant at screening visit
  • patients with para-functional habits like bruxing and clenching

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Javeriana

Bogotá, Colombia

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Armando Estefan, DMD

    Universidad Javeriana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

December 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

CO(1)